Pegcetacoplan History and Updates

110 events · 2014 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 16, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-16Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Pegcetacoplan since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (10)

2025

Primary completionSyfovre (Pegcetacoplan) Phase 3 Trial for Geographic Atrophy Primary Completion· Dec 12, 2025
Primary completionPegcetacoplan PNH Long-Term Extension Study Completes Primary Phase· Nov 29, 2025
Results postedPegcetacoplan Trial Results Posted for TA-TMA: PK Parameters Detailed· Nov 28, 2025
Results postedPegcetacoplan Phase 3 CAD Trial Results Posted: Increased Hemoglobin vs. Placebo· Oct 30, 2025
Primary completionPegcetacoplan Long-term GA Extension Study Completes Primary Phase· Sep 5, 2025
Primary completionPegcetacoplan Phase 3 Extension Study for PNH Reaches Primary Completion· Sep 4, 2025
Results postedPegcetacoplan Phase 3 Trial Shows Reduced Proteinuria in C3G/IC-MPGN· Aug 6, 2025
FDA approval (supplemental)Empaveli (Pegcetacoplan) Receives FDA Supplemental Efficacy Approval· Jul 28, 2025
Results postedPegcetacoplan ALS Trial Shows No Efficacy, Higher Adverse Events· Apr 24, 2025
Results postedPegcetacoplan Phase 2 Trial: C3G/IC-MPGN Post-Transplant Patients Show C3c…· Feb 7, 2025

Upcoming & expected milestones

Primary completionAug 15, 2026· ClinicalTrials.gov

Primary completion: NCT05776472

A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary completionOct 16, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06722157

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Primary completionOct 28, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06722157

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Trial startedOct 31, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07495722

Safely Quenching Complement in Stroke Survivors

Primary completionJan 3, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT06961370

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants W

Primary completionApr 30, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT07495722

Safely Quenching Complement in Stroke Survivors

Primary completionJun 30, 2027· ClinicalTrials.gov

Primary completion: NCT06161584

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of P

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07215390

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of

Primary completionJul 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05809531

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants Wit

Primary completionAug 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07020832

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney

Primary completionFeb 16, 2028· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07214298

Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

Primary completionApr 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT04919629

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopi

Primary completionDec 31, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT04901936

A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary completionOct 31, 2029· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07160179

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secon

Past events

2026

Trial registeredMar 27, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07495722

Safely Quenching Complement in Stroke Survivors

Trial startedFeb 28, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07020832

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney

Trial startedFeb 16, 2026· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07214298

Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

2025

Primary completionDec 12, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT07214740

Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe

Primary completionNov 29, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT03531255

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Results postedNov 28, 2025· ClinicalTrials.gov

Trial results posted: NCT05148299

A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation

Results postedOct 30, 2025· ClinicalTrials.gov

Trial results posted: NCT05096403

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Trial startedOct 24, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07214740

Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe

Trial registeredOct 10, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07215390

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of

Trial registeredOct 9, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07214298

Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

Trial registeredOct 9, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07214740

Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe

Trial registeredSep 8, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07160179

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secon

Primary completionSep 5, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT04770545

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to A

Primary completionSep 4, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT03531255

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Trial startedAug 13, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07160179

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secon

Results postedAug 6, 2025· ClinicalTrials.gov

Trial results posted: NCT05067127

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferativ

FDA approval (supplemental)Jul 28, 2025· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — Efficacy (NDA 215014 S-11)

Sponsor: APELLIS PHARMS. Class: Efficacy.

Trial startedJul 16, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06961370

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants W

Trial startedJun 23, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT07215390

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of

Trial registeredJun 13, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07020832

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney

FDA approval (supplemental)Jun 10, 2025· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — Labeling (NDA 215014 S-10)

Sponsor: APELLIS PHARMS. Class: Labeling.

Trial registeredMay 7, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06961370

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants W

Results postedApr 24, 2025· ClinicalTrials.gov

Trial results posted: NCT04579666

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

FDA approval (supplemental)Mar 27, 2025· FDA

FDA approved supplemental application for Syfovre (pegcetacoplan) — Manufacturing (CMC) (NDA 217171 S-3)

Sponsor: APELLIS PHARMS. Class: Manufacturing (CMC).

Results postedFeb 7, 2025· ClinicalTrials.gov

Trial results posted: NCT04572854

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Trial startedJan 6, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06722157

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

2024

FDA approval (supplemental)Dec 20, 2024· FDA

FDA approved supplemental application for Syfovre (pegcetacoplan) — Labeling (NDA 217171 S-2)

Sponsor: APELLIS PHARMS. Class: Labeling.

Trial registeredDec 9, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06722157

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Primary completionDec 8, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05148299

A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation

FDA approval (supplemental)Oct 7, 2024· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — REMS (NDA 215014 S-8)

Sponsor: APELLIS PHARMS. Class: REMS.

Primary completionJun 26, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05067127

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferativ

Primary completionMay 27, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05096403

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

FDA approval (supplemental)Feb 8, 2024· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — Labeling (NDA 215014 S-6)

Sponsor: APELLIS PHARMS. Class: Labeling.

2023

Trial registeredDec 8, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06161584

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of P

FDA approval (supplemental)Nov 30, 2023· FDA

FDA approved supplemental application for Syfovre (pegcetacoplan) — Labeling (NDA 217171 S-1)

Sponsor: APELLIS PHARMS. Class: Labeling.

Trial startedSep 28, 2023· ClinicalTrials.gov

Trial started: NCT06161584

A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of P

FDA approval (supplemental)Sep 28, 2023· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — Labeling (NDA 215014 S-3)

Sponsor: APELLIS PHARMS. Class: Labeling.

Trial startedJun 26, 2023· ClinicalTrials.gov

Trial started: NCT05776472

A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial startedMay 29, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05809531

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants Wit

Trial startedApr 27, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT04919629

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopi

Trial registeredApr 12, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05809531

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants Wit

Primary completionMar 31, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04579666

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Trial registeredMar 20, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05776472

A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary completionFeb 27, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04572854

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

FDA approvalFeb 17, 2023· FDA

FDA approved Syfovre (pegcetacoplan) (NDA 217171)

Sponsor: APELLIS PHARMS. Class: Type 3 - New Dosage Form.

FDA approval (supplemental)Feb 8, 2023· FDA

FDA approved supplemental application for Empaveli (pegcetacoplan) — Efficacy (NDA 215014 S-2)

Sponsor: APELLIS PHARMS. Class: Efficacy.

2022

Trial startedOct 20, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05096403

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Results postedMar 25, 2022· ClinicalTrials.gov

Trial results posted: NCT03500549

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial startedFeb 1, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05148299

A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation

2021

Trial registeredDec 8, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05148299

A Study of Pegcetacoplan for Patients With Transplant-associated Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplantation

Trial startedNov 12, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05067127

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferativ

Trial registeredOct 27, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05096403

A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)

Trial registeredOct 5, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05067127

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferativ

Trial startedSep 7, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04572854

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Trial registeredJun 9, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04919629

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopi

Trial registeredMay 26, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04901936

A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

FDA approvalMay 14, 2021· FDA

FDA approved Empaveli (pegcetacoplan) (NDA 215014)

Sponsor: APELLIS PHARMS. Class: Type 1 - New Molecular Entity.

Primary completionApr 1, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT03777332

Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy

Trial startedMar 4, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04770545

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to A

Trial registeredFeb 25, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04770545

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to A

Trial startedFeb 4, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04901936

A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial registeredJan 28, 2021· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT04729062

C3G/Primary IC-MPGN EAP

Results postedJan 11, 2021· ClinicalTrials.gov

Trial results posted: NCT02588833

Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.

Results postedJan 8, 2021· ClinicalTrials.gov

Trial results posted: NCT02264639

A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH

2020

Results postedDec 22, 2020· ClinicalTrials.gov

Trial results posted: NCT03593200

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With

Trial registeredOct 8, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04579666

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Results postedOct 6, 2020· ClinicalTrials.gov

Trial results posted: NCT02503332

Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy

Results postedOct 6, 2020· ClinicalTrials.gov

Trial results posted: NCT02461771

Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

Trial registeredOct 1, 2020· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04572854

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Trial startedSep 30, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04579666

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Results postedSep 16, 2020· ClinicalTrials.gov

Trial results posted: NCT03465709

Pegcetacoplan (APL-2) in Neovascular AMD

2019

Primary completionNov 14, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT03500549

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary completionOct 22, 2019· ClinicalTrials.gov

Phase 2 primary completion: NCT03593200

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With

Primary completionAug 26, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT02588833

Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.

Primary completionApr 5, 2019· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT03465709

Pegcetacoplan (APL-2) in Neovascular AMD

2018

Trial registeredDec 17, 2018· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03777332

Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy

Trial startedNov 5, 2018· ClinicalTrials.gov

Phase 1 trial started: NCT03777332

Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy

Primary completionOct 22, 2018· ClinicalTrials.gov

Phase 1 primary completion: NCT02264639

A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH

Trial startedAug 27, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03531255

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Trial startedAug 16, 2018· ClinicalTrials.gov

Phase 2 trial started: NCT03593200

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With

Trial registeredJul 20, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03593200

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With

Trial startedJun 14, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03500549

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial registeredMay 21, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03531255

Pegcetacoplan Long Term Safety and Efficacy Extension Study

Trial registeredApr 18, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03500549

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial registeredMar 14, 2018· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT03465709

Pegcetacoplan (APL-2) in Neovascular AMD

Trial startedFeb 14, 2018· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT03465709

Pegcetacoplan (APL-2) in Neovascular AMD

2017

Primary completionJul 14, 2017· ClinicalTrials.gov

Phase 2 primary completion: NCT02503332

Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy

2016

Primary completionMar 8, 2016· ClinicalTrials.gov

Phase 1 primary completion: NCT02461771

Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

2015

Trial startedDec 1, 2015· ClinicalTrials.gov

Phase 1 trial started: NCT02588833

Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.

Trial registeredOct 28, 2015· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02588833

Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.

Trial startedSep 24, 2015· ClinicalTrials.gov

Phase 2 trial started: NCT02503332

Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy

Trial registeredJul 20, 2015· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02503332

Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy

Trial registeredJun 3, 2015· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02461771

Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

Trial startedFeb 23, 2015· ClinicalTrials.gov

Phase 1 trial started: NCT02264639

A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH

Trial startedJan 28, 2015· ClinicalTrials.gov

Phase 1 trial started: NCT02461771

Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

2014

Trial registeredOct 15, 2014· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02264639

A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.